Bone Atrophy, AlveolarNCT06125938
Comparative Study Between Autogenous Bone Block and Tent Pole Technique for Augmentation of Atrophic Anterior Maxilla
A study testing tent pole technique and Autogenous bone block technique in people with Bone Atrophy, Alveolar, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare in patients with atrophied anterior maxilla, bone augmentation techniques ( gold standard bone block and tent pole technique). The main question it aims to answer is : Does screw tent pole technique provides better bone gain than autogenous bone block in atrophied anterior… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Atrophy, Alveolar
- What is being tested?
- tent pole technique and Autogenous bone block technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- systemically healthy patients (American Society of Anesthesiologists -ASA I and II); older than 18 years
- Patients with atrophic anterior maxilla ,with initial ridge wi¬dth of ≤ 5 mm and moderate bone height as diagnosed at the time of digital implant planning
- No intraoral soft and hard tissue pathology.
- Cone Beam Computer Tomography scan before and after bone augmentation.
- Apprehensive to be in the study
Who cannot join
- Bad oral hygiene.
- smokers (>10 cigarettes/day);
- Existence of a bone metabolic disease; currently taking drugs that might influence bone metabolism
- Radiotherapy or chemotherapy for malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Autogenous Bone Block and Tent Pole Technique for Augmentation of Atrophic Anterior Maxilla A Randomized Clinical Trial
The goal of this clinical trial is to compare in patients with atrophied anterior maxilla, bone augmentation techniques ( gold standard bone block and tent pole technique).
The main question it aims to answer is :
Does screw tent pole technique provides better bone gain than autogenous bone block in atrophied anterior maxilla?
- primary objective to assess amount of bone gain
- secondary objective assess bone quality Participants will be randomly divided into two groups study group ( tent pole technique) and control group ( bone block) - each group will be followed up monthly for soft tissue dehiscence and after 6 month to assess bone gain and bone quality and then implant placement.
Read the detailed description
- Research question: Does screw tent pole technique provides better bone gain than autogenous bone block in atrophied anterior maxilla?
- Rationale for conducting the research: Several methods have been developed for the augmentation of the deficient bone volume. These include Guided Bone Regeneration (GBR) with barrier membranes, onlay bone grafting, ridge splitting and distraction osteogenesis.
The screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies. Previous studies have proven that screw tent pole technique is recommended in reconstruction of atrophied alveolar bone and its good outcome in contrary to other bone graft techniques.
This study aim to compare the outcome of screw tent pole technique to conventional gold standard technique of block bone grafts in atrophied anterior maxilla.
- Primary and secondary objectives:
- primary objective to assess amount of bone gain
- secondary objective assess bone quality . Trial design: Randomized clinical trial, Unicentered, Parallel groups, 2 arms, Allocation ratio 1:1, Equivalent trial • PICO: Population: patients with atrophied Anterior Maxillary area (with initial ridge width of ≤ 5 mm and moderate bone height) Intervention: Screw Tent-Pole technique Control group: Autogenous Bone Block technique Outcome: bone gain , histomorphometric evaluations, dehiscence.
- Interventions
- Surgical Protocol
- Screw Tent pole technique
- A prophylactic antibiotics administration was conducted.
- All surgical procedures were performed under local anesthesia.
- A trapezoid incision will be formed to expose the edentulous alveolar ridge in recipient site.
- A full-thickness flap will be retracted to expose the alveolar bone. 5
- Titanium screws (1.5 mm) will be placed perpendicular to alveolar bone so that approximately 5 to 7 mm of screw threat will be exposed.
- A posterior releasing incision was made over ramus to provide access to the donor site.
- Autogenous bone graft taken from donor site area using ACM bur
- The autogenous particles obtained from the donor site will be mixed with xenograft in a 50/50 ratio.
- PRF membrane is then prepared ( PRF membrane formed by withdrawing blood sample from patient into a tube , the tube will be transferred to centrifuge machine -2500 RPM for 10 minutes) and is pierced through the healing abutment and used to cover the bone graft to accelerate wound healing by preventing soft tissue ingrowth.
- A tension-free suture will be completed.
- After 6 months of healing:
A full-thickness flap is retracted to expose the alveolar bone (augmented site).
The screw will be removed, Histopathological biopsy sample of bone will be taken using trephine bur (the same size as pilot drill) and sequential drilling will be done for implant placement at the same visit.
- Autogenous bone block technique
- A prophylactic antibiotics administration was conducted.
- All surgical procedures were performed under local anesthesia.
- A trapezoid incision will be formed to expose the edentulous alveolar ridge in recipient site.
- A full-thickness flap will be retracted to expose the alveolar bone.
- A posterior releasing incision was made over ramus to provide access to the donor site.
- The size of the ramus graft will be determined from the recipient site, and bone osteotomy of cortical and cancellous bone will be done by Piezo-electric bone surgery.
- The outlined graft was mobilized from its bed using chisels and the bone block will be placed in defected anterior maxilla and stabilized using micro screws.
- particulate Autogenous bone graft will also be taken from donor site area using ACM bur and mixed with xenograft in a 50/50 ratio and then placed to fill the space in between the bone block.
- PRF membrane is then prepared ( PRF membrane formed by withdrawing blood sample from patient into a tube , the tube will be transferred to centrifuge machine -2500 RPM for 10 minutes) and is pierced through the healing abutment and used to cover the bone graft to accelerate wound healing by preventing soft tissue ingrowth.
- A tension-free suture will be completed.
- After 6 months of healing:
A full-thickness flap is retracted to expose the alveolar bone (augmented site).
The screw will be removed, Histopathological biopsy sample of bone will be taken using trephine bur (the same size as pilot drill) and sequential drilling will be done for implant placement at the same visit.
- Post-operative care:
- Avoid traumatization of the surgical site.
- Patients must abstain from brushing the surgical area. Instead, a disinfecting mouth rinse should be used (e.g. chlorhexidine 0.2%).
- ·Instruct the patient not to touch or manipulate the surgical area.
- ·Ice packs for 10 minutes every 30 minutes for 24 hours.
- Do not use removable dentures during the expansion phase. Temporary fixed partial dentures must be adjusted to the expected tissue gain.
- ·No consume of tobacco
- ·Post-operative medications will be prescribed as follows:
- Amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, diclofenac potassium 50mg every 8 hours for 4 days and then as needed, metronidazole 5 mg/kg every 8 hours for 7 days and chlorhexidine gluconate
- 0.1% mouthwash 3 times daily for 14 days.
Clinical follow up:
-The dehiscence will be followed up every month.
Radiographic follow up:
-Immediately after surgery and after six months, CBCT will be obtained to evaluate bone gain in each group
- Conditions
- Bone Atrophy, Alveolar
- Being tested
- tent pole technique, Autogenous bone block technique
- Keywords
- bone augmentation ,tent pole
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tent pole techniqueProcedure or surgery
The screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies
Autogenous bone block techniqueProcedure or surgery
Bone block graft has been the gold standard for restoring deficient regions.
| Study group | Role | What they receive |
|---|---|---|
| tent pole technique | Experimental | The screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies Receives: Procedure: tent pole technique |
| autogenous bone block technique | Active comparator | Bone block graft has been the gold standard for restoring deficient regions. Receives: Procedure: Autogenous bone block technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Gain
to assess amount of bone gain before and after 6 month of the surgical procedure
Measured: 6 month
Secondary outcomes (1)
Bone quality evaluation
the bone quality through bone core biopsy by trephine bur will be evaluated in the two techniques after 6 months post-operative
Measured: 6 month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Oct 2023
- Primary completionApr 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Atrophy, AlveolarStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youmna Mohamed Mahmoud Hassan Abdelhady, Cairo University
- Investigators
- Youmna M Abdelhady, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125938
- Sponsor's protocol ID
- 40723
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Autogenous Bone Block and Tent Pole Technique for Augmentation of Atrophic Anterior Maxilla A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06125938
- Acronym / sponsor ID
- 40723
- Conditions
- Bone Atrophy, Alveolar
- Keywords
- bone augmentation ,tent pole
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare in patients with atrophied anterior maxilla, bone augmentation techniques ( gold standard bone block and tent pole technique).
The main question it aims to answer is :
Does screw tent pole technique provides better bone gain than autogenous bone block in atrophied anterior maxilla?
- primary objective to assess amount of bone gain
- secondary objective assess bone quality Participants will be randomly divided into two groups study group ( tent pole technique) and control group ( bone block) - each group will be followed up monthly for soft tissue dehiscence and after 6 month to assess bone gain and bone quality and then implant placement.
Detailed description
- Research question: Does screw tent pole technique provides better bone gain than autogenous bone block in atrophied anterior maxilla?
- Rationale for conducting the research: Several methods have been developed for the augmentation of the deficient bone volume. These include Guided Bone Regeneration (GBR) with barrier membranes, onlay bone grafting, ridge splitting and distraction osteogenesis.
The screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies. Previous studies have proven that screw tent pole technique is recommended in reconstruction of atrophied alveolar bone and its good outcome in contrary to other bone graft techniques.
This study aim to compare the outcome of screw tent pole technique to conventional gold standard technique of block bone grafts in atrophied anterior maxilla.
- Primary and secondary objectives:
- primary objective to assess amount of bone gain
- secondary objective assess bone quality . Trial design: Randomized clinical trial, Unicentered, Parallel groups, 2 arms, Allocation ratio 1:1, Equivalent trial • PICO: Population: patients with atrophied Anterior Maxillary area (with initial ridge width of ≤ 5 mm and moderate bone height) Intervention: Screw Tent-Pole technique Control group: Autogenous Bone Block technique Outcome: bone gain , histomorphometric evaluations, dehiscence.
- Interventions
- Surgical Protocol
- Screw Tent pole technique
- A prophylactic antibiotics administration was conducted.
- All surgical procedures were performed under local anesthesia.
- A trapezoid incision will be formed to expose the edentulous alveolar ridge in recipient site.
- A full-thickness flap will be retracted to expose the alveolar bone. 5
- Titanium screws (1.5 mm) will be placed perpendicular to alveolar bone so that approximately 5 to 7 mm of screw threat will be exposed.
- A posterior releasing incision was made over ramus to provide access to the donor site.
- Autogenous bone graft taken from donor site area using ACM bur
- The autogenous particles obtained from the donor site will be mixed with xenograft in a 50/50 ratio.
- PRF membrane is then prepared ( PRF membrane formed by withdrawing blood sample from patient into a tube , the tube will be transferred to centrifuge machine -2500 RPM for 10 minutes) and is pierced through the healing abutment and used to cover the bone graft to accelerate wound healing by preventing soft tissue ingrowth.
- A tension-free suture will be completed.
- After 6 months of healing:
A full-thickness flap is retracted to expose the alveolar bone (augmented site).
The screw will be removed, Histopathological biopsy sample of bone will be taken using trephine bur (the same size as pilot drill) and sequential drilling will be done for implant placement at the same visit.
- Autogenous bone block technique
- A prophylactic antibiotics administration was conducted.
- All surgical procedures were performed under local anesthesia.
- A trapezoid incision will be formed to expose the edentulous alveolar ridge in recipient site.
- A full-thickness flap will be retracted to expose the alveolar bone.
- A posterior releasing incision was made over ramus to provide access to the donor site.
- The size of the ramus graft will be determined from the recipient site, and bone osteotomy of cortical and cancellous bone will be done by Piezo-electric bone surgery.
- The outlined graft was mobilized from its bed using chisels and the bone block will be placed in defected anterior maxilla and stabilized using micro screws.
- particulate Autogenous bone graft will also be taken from donor site area using ACM bur and mixed with xenograft in a 50/50 ratio and then placed to fill the space in between the bone block.
- PRF membrane is then prepared ( PRF membrane formed by withdrawing blood sample from patient into a tube , the tube will be transferred to centrifuge machine -2500 RPM for 10 minutes) and is pierced through the healing abutment and used to cover the bone graft to accelerate wound healing by preventing soft tissue ingrowth.
- A tension-free suture will be completed.
- After 6 months of healing:
A full-thickness flap is retracted to expose the alveolar bone (augmented site).
The screw will be removed, Histopathological biopsy sample of bone will be taken using trephine bur (the same size as pilot drill) and sequential drilling will be done for implant placement at the same visit.
- Post-operative care:
- Avoid traumatization of the surgical site.
- Patients must abstain from brushing the surgical area. Instead, a disinfecting mouth rinse should be used (e.g. chlorhexidine 0.2%).
- ·Instruct the patient not to touch or manipulate the surgical area.
- ·Ice packs for 10 minutes every 30 minutes for 24 hours.
- Do not use removable dentures during the expansion phase. Temporary fixed partial dentures must be adjusted to the expected tissue gain.
- ·No consume of tobacco
- ·Post-operative medications will be prescribed as follows:
- Amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, diclofenac potassium 50mg every 8 hours for 4 days and then as needed, metronidazole 5 mg/kg every 8 hours for 7 days and chlorhexidine gluconate
- 0.1% mouthwash 3 times daily for 14 days.
Clinical follow up:
-The dehiscence will be followed up every month.
Radiographic follow up:
-Immediately after surgery and after six months, CBCT will be obtained to evaluate bone gain in each group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tent pole technique | Experimental | Procedure: tent pole techniqueThe screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies |
| autogenous bone block technique | Active comparator | Procedure: Autogenous bone block techniqueBone block graft has been the gold standard for restoring deficient regions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- systemically healthy patients (American Society of Anesthesiologists -ASA I and II); older than 18 years
- Patients with atrophic anterior maxilla ,with initial ridge wi¬dth of ≤ 5 mm and moderate bone height as diagnosed at the time of digital implant planning
- No intraoral soft and hard tissue pathology.
- Cone Beam Computer Tomography scan before and after bone augmentation.
- Apprehensive to be in the study
Key exclusion criteria (4 listed)
- Bad oral hygiene.
- smokers (>10 cigarettes/day);
- Existence of a bone metabolic disease; currently taking drugs that might influence bone metabolism
- Radiotherapy or chemotherapy for malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tent pole techniqueThe screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies | Procedure or surgery | tent pole technique |
| Autogenous bone block techniqueBone block graft has been the gold standard for restoring deficient regions. | Procedure or surgery | autogenous bone block technique |
Primary outcome
Bone Gain
Time frame: 6 month
to assess amount of bone gain before and after 6 month of the surgical procedure
1 secondary outcome
Bone quality evaluation
Time frame: 6 month post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youmna M Abdelhady principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tent pole technique and Autogenous bone block technique in people with Bone Atrophy, Alveolar, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youmna M Abdelhady (01066302239, youmna.abdelhady@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Gain (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.